According to the lawsuits, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that:
- FibroGen’s prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase 3 program for the treatment of anemia certain safety analyses submitted in connection with chronic kidney disease (“CKD”) included post-hoc changes to the stratification factors;
- FibroGen’s analyses with the pre-specified stratification factors result in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals;
- Based on these analyses, FibroGen could not conclude that roxadustat reduces the risk of (or is superior to) MACE+ in dialysis, and MACE and MACE+ in incident dialysis compared to epoetin-alfa;
- As a result, FibroGen faced significant uncertainty that its New Drug Application for roxadustat as a treatment for anemia of CKD would be approved by the FDA; and
- As a result of the foregoing, defendants’ statements about FibroGen’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
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